Study With Modafinil in Patients Treated With Docetaxel-Based Chemotherapy for Metastatic Breast or Prostate Cancer (MOTIF)

This study has been completed.

Sponsor:

Sanofi

ClinicalTrials.gov Identifier:

NCT00917748

First Posted: June 10, 2009

Last Update Posted: September 26, 2012

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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To determine the efficacy of modafinil in the reduction of fatigue in patients with metastatic breast or prostate cancer undergoing docetaxel-based chemotherapy

The secondary objectives are:

To determine the effect of modafinil on quality of life (QoL) during docetaxel-based chemotherapy

To determine the effect of modafinil on patients physical activity level, functional status, number of chemotherapy cycles tolerated, sleep disturbance and depression, during docetaxel-based chemotherapy

To investigate the impact of tumour type, patient physical activity level, functional status, sleep disturbance and depression on the efficacy of modafinil at improving fatigue and quality of life during docetaxel-based chemotherapy.

To determine the safety and tolerability of modafinil during docetaxel-based chemotherapy

A Prospective, Randomised, Double-Blind, Placebo-Controlled Phase III Study of Modafinil to Improve Fatigue and Quality of Life in Patients Treated With Docetaxel-Based Chemotherapy for Metastatic Breast or Prostate Cancer

Fatigue scores daily assessed using the 11-point (0-10) 0 is the lower score and 10 is the highest. this score is calculated using the MD Anderson Symptom Inventory [ Time Frame: From baseline to the end of study (week 12) ]

Secondary Outcome Measures:

Patient quality of life weekly assessed by using the self-administered Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Quality Of Life survey [ Time Frame: From baseline to the end of study (week 12) ]

Fatigue assessed by using the self-administered six-item somatic subscale (SOMA) of the Somatic and Psychological Health Report (SPHERE) questionnaire [ Time Frame: At screening and from visit 6 (week 3) of treatment to end of study (week 12) ]

Sleep quality assessed by using the self-administered Pittsburgh Sleep Quality Index (PSQI) questionnaire [ Time Frame: At baseline and from visit 6 (week 3) to end of study (week 12) ]

Functional status will be determined using the self-administered Medical Outcomes Study - Short Form Health Survey (SF-36) [ Time Frame: At baseline and from visit 6 (week 3) to end of study (week 12) ]

Depression assessed using seven depression-related questions from the self-administered Hospital Anxiety and Depression (HAD) assessment subscale. Patient with depression will be defined as having the HAD-D> or = 8 [ Time Frame: At baseline and last visit= end of study (week 12) ]

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Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion criteria:

Treatment with q3w (every three weeks) docetaxel-based chemotherapy for metastatic breast or prostate cancer at a minimum dose of 50 mg/m2

Completed at least two cycles of chemotherapy and intention to treat the patient with at least two further cycles of docetaxel-based chemotherapy